Transplant Failure or Rejection of Bone Marrow (Graft vs Host Disease, GVHD)Phase 1NCT07913672
A Study of LBP-MARCO and Ruxolitinib in People With Graft-Versus-Host Disease (GVHD)
A Phase 1 study testing Ruxolitinib and LBP- MARCO in people with Transplant Failure or Rejection of Bone Marrow (Graft vs Host Disease, GVHD), run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The researchers are doing this study to find out whether the combination of LBP-MARCO (Microbiota Augmentation to Reestablish Commensal Organisms) and ruxolitinib is a safe treatment for people with graft-versus-host disease (GVHD) after receiving a stem cell (allogeneic hematopoietic cell transplantation). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant Failure or Rejection of Bone Marrow (Graft vs Host Disease, GVHD)
- What is being tested?
- Ruxolitinib and LBP- MARCO
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 7 sitesUnited States
- Study dates
- 27 Oct 2026to 27 Oct 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Ability to swallow capsules
- Have undergone allo-HCT from any donor source
- Upper GI aGVHD stage 1 and/or lower GI aGVHD stage 1-4. aGVHD affecting other organs (e.g. skin, liver) are allowed
- Steroid-refractory, steroid-dependent or intolerant, defined as:
- Progressive (i.e., increase in stage of the lower GI tract) after 3 days of treatment with corticosteroids (≥1 mg/kg/day prednisone or IV equivalent), or
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- Failure to improve (i.e., decrease in stage in the GI tract) after 5 days of corticosteroid treatment (≥1 mg/kg/day prednisone or IV equivalent), or
- Incomplete response after >28 days of corticosteroids, or
- Corticosteroid dependent (inability to taper prednisone <1 mg/kg/day or recurrence of aGVHD activity or flare during steroid taper), or
- Corticosteroid intolerance (unacceptable toxicity due to the use of corticosteroids).
- Absolute neutrophil count (ANC) ≥0.5 x10^9/L and platelets >20,000/mm3. Use of growth factor supplementation and platelet transfusional support is allowed
- Ability to start ruxolitinib therapy for aGVHD
Who cannot join
- Has received more than one systemic treatment for aGVHD other than corticosteroids +/- CNI or sirolimus prophylaxis or treatment
- Active GI bleeding requiring intervention or transfusional support
- Toxic megacolon
- Active uncontrolled infection requiring systemic antibiotic treatment including persistent bacteremia (controlled infection receiving definitive therapy for 48 hours prior to enrollment are eligible).
- Treatment with broad spectrum antibiotic with anaerobic coverage for 48 hours prior to enrollment
- Elevated total bilirubin not caused by GVHD or Gilbert's disease of >5 x upper limit of normal (ULN)
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- Use of investigational agent within 14 days pre-treatment
- Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months
- Uncontrolled psychiatric illness
- Patients with an active secondary malignancy or prior malignancy requiring systemic therapy within the past 3 years. Exceptions include adequately treated localized non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma), as well as localized prostate cancer considered low risk and stable under treatment or surveillance
- Female patient who is pregnant or breastfeeding
- Known allergy or sensitivity to ruxolitinib and/or MARCO live biotherapeutic
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jonathan Peled, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920
Doris Ponce, MD, 646-608-3739
- Recruiting
Memorial Sloan Kettering Suffolk-Commack (Consent Only)
Commack, New York, 11725
Doris Ponce, MD, 646-608-3739
- Recruiting
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, 10604
Doris Ponce, MD, 646-608-3739
- Recruiting
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, 07748
Doris Ponce, MD, 646-608-3739
- Recruiting
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645
Doris Ponce, MD, 646-608-3739
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Doris Ponce, MD, 646-608-3739
- Recruiting
Memorial Sloan Kettering Nassau (Consent Only)
Rockville Centre, New York, 11553
Doris Ponce, MD, 646-608-3739
About this study
Official title: Pilot Study of Live Biotherapeutic Product (LBP) MARCO (Microbiota Augmentation to Reestablish Commensal Organisms) Combined With Ruxolitinibfor Patients With Steroid Refractory or Intolerant Gastrointestinal Acute Graft-versus-Host Disease (aGVHD) After Allogeneic Cell Transplantation (Allo-HCT) (MARCO-GVHD Trial)
The researchers are doing this study to find out whether the combination of LBP-MARCO (Microbiota Augmentation to Reestablish Commensal Organisms) and ruxolitinib is a safe treatment for people with graft-versus-host disease (GVHD) after receiving a stem cell (allogeneic hematopoietic cell transplantation).
- Being tested
- Ruxolitinib, LBP- MARCO
- Keywords
- Rauxolitinibfor, Live Biotherapeutic Product, Microbiota Augmentation to Reestablish Commensal Organisms), allo-HCT
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
Also called Jakafi®
Ruxolitinib will be initiated concurrently with LBP treatment at a starting dose of 10 mg twice daily and will continue for at least 28 days.
LBP- MARCOOther
The LBP-MARCO consists of five capsules of individual bacterial strains that will be given at least 1 day apart from one another and within 7-10 days of the first dose.
| Study group | Role | What they receive |
|---|---|---|
| Consortia A | Experimental | Participants in Cohort 1 will receive LBP-MARCO with the same combination of 7 specific types of bacteria. Receives: Drug: Ruxolitinib; Other: LBP- MARCO |
| Consortia B | Experimental | If the bacteria do not grow or produce enough metabolites, the next group of participants (Cohort 2) will get LBP-MARCO with a different combination of bacteria. Receives: Drug: Ruxolitinib; Other: LBP- MARCO |
| Consortia C | Experimental | If that combination does not grow in participants' guts, the next group of participants (Cohort 3) will get LBP-MARCO with a different combination of the bacteria. Receives: Drug: Ruxolitinib; Other: LBP- MARCO |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence and severity of SAEs
Grade 2-4 infections by CTCAE v6 either clinically or microbiologically will be assessed throughout the study until day +100. Causality and relationship with aGVHD, LBP-MARCO, and ruxolitinib will be determined.
Measured: up to 100 days
Secondary outcomes (1)
Microbiota engraftment/PK
is defined as the detection of > or = to 5 of the 7 consortia commensal strains including butyrate producing taxa detected in stool samples
Measured: day +7 and/or +14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start27 Oct 2026
- Primary completion27 Oct 2028 (estimated)
- Study completion27 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant Failure or Rejection of Bone Marrow (Graft vs Host Disease, GVHD)Studies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is non-randomized, prospective, pilot study.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago
- Responsible party
- Sponsor
- Investigators
- Doris Ponce, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913672
- Sponsor's protocol ID
- 26-268
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Live Biotherapeutic Product (LBP) MARCO (Microbiota Augmentation to Reestablish Commensal Organisms) Combined With Ruxolitinibfor Patients With Steroid Refractory or Intolerant Gastrointestinal Acute Graft-versus-Host Disease (aGVHD) After Allogeneic Cell Transplantation (Allo-HCT) (MARCO-GVHD Trial)
- ClinicalTrials.gov ID
- NCT07913672
- Acronym / sponsor ID
- 26-268
- Keywords
- Rauxolitinibfor, Live Biotherapeutic Product, Microbiota Augmentation to Reestablish Commensal Organisms), allo-HCT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- University of Chicago
- Study start
- 27 Oct 2026 (actual)
- Primary completion
- 27 Oct 2028 (estimated)
- Study completion
- 27 Oct 2028 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers are doing this study to find out whether the combination of LBP-MARCO (Microbiota Augmentation to Reestablish Commensal Organisms) and ruxolitinib is a safe treatment for people with graft-versus-host disease (GVHD) after receiving a stem cell (allogeneic hematopoietic cell transplantation).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is non-randomized, prospective, pilot study.
| Arm | Type | Receives |
|---|---|---|
| Consortia A | Experimental | Drug: Ruxolitinib, Other: LBP- MARCOParticipants in Cohort 1 will receive LBP-MARCO with the same combination of 7 specific types of bacteria. |
| Consortia B | Experimental | Drug: Ruxolitinib, Other: LBP- MARCOIf the bacteria do not grow or produce enough metabolites, the next group of participants (Cohort 2) will get LBP-MARCO with a different combination of bacteria. |
| Consortia C | Experimental | Drug: Ruxolitinib, Other: LBP- MARCOIf that combination does not grow in participants' guts, the next group of participants (Cohort 3) will get LBP-MARCO with a different combination of the bacteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18
- Ability to swallow capsules
- Have undergone allo-HCT from any donor source
- Upper GI aGVHD stage 1 and/or lower GI aGVHD stage 1-4. aGVHD affecting other organs (e.g. skin, liver) are allowed
- Absolute neutrophil count (ANC) ≥0.5 x10^9/L and platelets >20,000/mm3. Use of growth factor supplementation and platelet transfusional support is allowed
Key exclusion criteria (12 listed)
- Has received more than one systemic treatment for aGVHD other than corticosteroids +/- CNI or sirolimus prophylaxis or treatment
- Active GI bleeding requiring intervention or transfusional support
- Toxic megacolon
- Active uncontrolled infection requiring systemic antibiotic treatment including persistent bacteremia (controlled infection receiving definitive therapy for 48 hours prior to enrollment are eligible).
- Treatment with broad spectrum antibiotic with anaerobic coverage for 48 hours prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RuxolitinibAlso: Jakafi®Ruxolitinib will be initiated concurrently with LBP treatment at a starting dose of 10 mg twice daily and will continue for at least 28 days. | Drug | Consortia A, Consortia B, Consortia C |
| LBP- MARCOThe LBP-MARCO consists of five capsules of individual bacterial strains that will be given at least 1 day apart from one another and within 7-10 days of the first dose. | Other | Consortia A, Consortia B, Consortia C |
Primary outcome
incidence and severity of SAEs
Time frame: up to 100 days
Grade 2-4 infections by CTCAE v6 either clinically or microbiologically will be assessed throughout the study until day +100. Causality and relationship with aGVHD, LBP-MARCO, and ruxolitinib will be determined.
1 secondary outcome
Microbiota engraftment/PK
Time frame: day +7 and/or +14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan Peled, MD contact
Doris Ponce, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ruxolitinib and LBP- MARCO in people with Transplant Failure or Rejection of Bone Marrow (Graft vs Host Disease, GVHD), run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doris Ponce, MD (646-608-3739, ponced@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence and severity of SAEs (time frame: up to 100 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.